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276.66 sec. 001 - Topics in Pharmaceutical Policy: the Case of Biotherapeutics (Spring 2023)
Instructor: Rachel Zuraw (view instructor's teaching evaluations - degree students only)
View all teaching evaluations for this course - degree students only
Grading Designation: Credit Only
Mode of Instruction: In-Person
W 6:25 PM - 8:15 PM
Location: Law 115
From February 22, 2023
To April 12, 2023
Course End: April 12, 2023
Class Number: 32334
Enroll Limit: 24
As of: 08/24 11:03 PM
Biotherapeutics, which has been widely hailed as the fastest-growing sector in the pharmaceutical industry, have been much in the news lately -- and not solely due to the use of monoclonal antibodies to treat COVID-19. Revenues are already in the hundreds of billions, and given that biologics (treatments derived from living cells) make up more than 50% of drugs currently in development, this is only predicted to increase. Furthermore, the development and repurposing of treatments and vaccines to counter the COVID-19 global pandemic has made the world interested in further possibilities.
So, why have this course at a law school? Biologics are taking off at a time when we are wrestling with global intellectual property rights in the pharmaceutical industry. In this course we will use case studies from the United States, the European Union, and India to explore the impact of the gaps, conflicts, and overlaps in different countries’ patent systems and marketing approvals on the pricing and accessibility of pharmaceutical products. Students will learn to consider and compare different methods of intellectual property protection for biologic drugs, as well as how to apply ethical frameworks to consider their impact.
This course has no prerequisites; there will be an overview at the outset of the patentability of biologic products that will provide a sufficient basis for the expected level of discussion. The course is particularly designed to benefit and seek input from students with international practice experience, though both LL.M. and J.D. students are encouraged to enroll.
Professor Zuraw earned her J.D. and Master's in Bioethics from the University of Pennsylvania, and has taught courses in law and bioethics at Drexel University Thomas R. Kline School of Law and the University of Pennsylvania School of Arts and Sciences. She subsequently practiced at firms in the Bay Area for several years in the areas of health care and complex intellectual property litigation.
Attendance at the first class is mandatory for all currently enrolled and waitlisted students; any currently enrolled or waitlisted students who are not present on the first day of class (without prior permission of the instructor) will be dropped. The instructor will continue to take attendance throughout the add/drop period and anyone who moves off the waitlist into the class must continue to attend or have prior permission of the instructor in order not to be dropped.
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